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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K101685
Device Name IP-SET
Applicant
Integral Process Sas
12 Rue Des Cayennes
Pb 310
Conflans Sainte Honorine,  FR 78703
Applicant Contact CHRISTIAN BERTHON
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/16/2010
Decision Date 07/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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